Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Recruiting at134 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

Research Team

Eligibility Criteria

Inclusion Criteria

Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)

Fasting C-peptide >= 1 ng/mL

Body mass index <= 40 kg/m2

Treatment Details

Interventions

• Metformin (Biguanide)
• Placebo matching Metformin (Drug)
• Placebo matching Saxagliptin (Drug)
• Saxagliptin (Dipeptidyl Peptidase-4 (DPP-4) Inhibitor)

Participant Groups

Group I: Saxagliptin 5 mg (B) Experimental Treatment 3 Interventions

Metformin 500-2000 mg (as needed for rescue)

Group II: Saxagliptin 2.5 mg (A) Experimental Treatment 3 Interventions

Metformin 500-2000 mg (as needed for rescue)

Group III: Saxagliptin 10 mg (C) Experimental Treatment 3 Interventions

Metformin 500-2000 mg (as needed for rescue)

Group IV: Open-Label Treatment Cohort (Direct Enrollees) (E) Experimental Treatment 2 Interventions

Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)

Group V: Placebo (D) Placebo Group 2 Interventions

Metformin 500-2000 mg (as needed for rescue)

Saxagliptin is already approved in Canada, Japan for the following indications:

Approved in Canada as Onglyza for:

• Type 2 diabetes

Approved in Japan as Onglyza for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology